carbidopa, levodopa and entacapone

Product NDC: 55648-784
11-digit product format: 556480784
Labeler code: 55648
Product ID: 55648-784_9866a9f3-77fb-43ec-b516-2a4dac01e1cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbidopa, levodopa and entacapone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Wockhardt Limited
Application: NDA021485
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2012-02-29
Marketing end: 0000-00-00
Substance: CARBIDOPA; ENTACAPONE; LEVODOPA
Active strength: 25 mg/1; mg/1; mg/1
Pharmacologic classes: Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55648-784		I	Inactivated by FDA	2026-08-17
excluded package	package	55648-784	55648-784-02	I	Inactivated by FDA	2026-08-17
excluded package	package	55648-784	55648-784-03	I	Inactivated by FDA	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-784-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-784-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-784-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-784-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-784-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-784-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-784-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-784-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-784-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-784-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-784-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-784-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-784-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-784-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-784-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-784-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-784-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-784-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-784-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-784-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55648-784-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55648-784-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55648-784-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55648-784-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-784-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-784-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-784-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-784-03	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-784-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-784-03	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55648-784-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55648-784-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55648-784-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55648-784-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55648-784-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55648-784-03	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55648-784-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55648-784-03	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55648-784-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55648-784-03	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021485-001	STALEVO 50	CARBIDOPA; ENTACAPONE; LEVODOPA	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11
N021485-002	STALEVO 100	CARBIDOPA; ENTACAPONE; LEVODOPA	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11
N021485-003	STALEVO 150	CARBIDOPA; ENTACAPONE; LEVODOPA	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11
N021485-004	STALEVO 200	CARBIDOPA; ENTACAPONE; LEVODOPA	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02
N021485-005	STALEVO 75	CARBIDOPA; ENTACAPONE; LEVODOPA	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29
N021485-006	STALEVO 125	CARBIDOPA; ENTACAPONE; LEVODOPA	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N021485-001	AB
N021485-002	AB
N021485-003	AB
N021485-004	AB
N021485-005	AB
N021485-006	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-005	STALEVO 75	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-006	STALEVO 125	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-005	STALEVO 75	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-006	STALEVO 125	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-005	STALEVO 75	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-006	STALEVO 125	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-005	STALEVO 75	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-006	STALEVO 125	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-005	STALEVO 75	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-006	STALEVO 125	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-005	STALEVO 75	18.75MG;200MG;75MG	TABLET / ORAL	AB	RLD	2008-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-006	STALEVO 125	31.25MG;200MG;125MG	TABLET / ORAL	AB	RLD	2008-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021485-001	STALEVO 50	12.5MG;200MG;50MG	TABLET / ORAL	AB	RLD, RS	2003-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021485-002	STALEVO 100	25MG;200MG;100MG	TABLET / ORAL	AB	RLD	2003-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021485-003	STALEVO 150	37.5MG;200MG;150MG	TABLET / ORAL	AB	RLD	2003-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021485-004	STALEVO 200	50MG;200MG;200MG	TABLET / ORAL	AB	RLD, RS	2007-08-02	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021485-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021485-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021485-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021485-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021485-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021485-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021485-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021485-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021485-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021485-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021485-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021485-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021485-004	AB	1	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021485-001	6500867	2020-06-29	U-219	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-001	6797732	2020-06-29		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-002	6500867	2020-06-29	U-219	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-002	6797732	2020-06-29		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-003	6500867	2020-06-29	U-219	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-003	6797732	2020-06-29		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-004	6500867	2020-06-29	U-219	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-004	6797732	2020-06-29		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-005	6500867	2020-06-29	U-219	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-005	6797732	2020-06-29		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-006	6500867	2020-06-29	U-219	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021485-006	6797732	2020-06-29		Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021485-001	6500867	2020-06-29	U-219	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-001	6797732	2020-06-29		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-002	6500867	2020-06-29	U-219	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-002	6797732	2020-06-29		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-003	6500867	2020-06-29	U-219	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-003	6797732	2020-06-29		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-004	6500867	2020-06-29	U-219	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-004	6797732	2020-06-29		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-005	6500867	2020-06-29	U-219	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-005	6797732	2020-06-29		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-006	6500867	2020-06-29	U-219	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021485-006	6797732	2020-06-29		Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021485-001	6500867	2020-06-29	U-219	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-001	6797732	2020-06-29		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-002	6500867	2020-06-29	U-219	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-002	6797732	2020-06-29		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-003	6500867	2020-06-29	U-219	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-003	6797732	2020-06-29		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-004	6500867	2020-06-29	U-219	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-004	6797732	2020-06-29		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-005	6500867	2020-06-29	U-219	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-005	6797732	2020-06-29		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-006	6500867	2020-06-29	U-219	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021485-006	6797732	2020-06-29		Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021485-001	6500867	2020-06-29	U-219	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021485-001	6797732	2020-06-29		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021485-002	6500867	2020-06-29	U-219	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021485-002	6797732	2020-06-29		Drug product	`3f01610625f2…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ce6fab2-d006-4589-8ba0-02cee499cc60	Product name	2	20260128
ebf3b793-6fcd-797b-9d2e-c3faf6d29442	Product name	5	20251106
162160fe-5ea6-4f9d-aa38-c4b780c57046	Product name	1	20250515
0e5ae331-9620-4d1f-8061-7c437c7f1c42	Product name	1	20250312
028fdaca-77da-0dfe-e445-7dfc440fc97e	Product name	4	20250224
7d015b89-35e8-b484-e5db-c0c44814f63c	Product name	7	20241218
6a098371-84f5-7ced-0ac5-ed90d535b476	Product name	6	20220927
de702a02-e9c0-4daf-9101-e44f2c0d4e66	Product name	1	20220609
681917df-580c-4199-896d-b739fbb25ed3	Product name	1	20190412
7d015b89-35e8-b484-e5db-c0c44814f63c	Product name	4	20171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41	Product name	1	20150313
88839c8d-b65b-4a50-997b-4c74539855ff	Product name	1	20150313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55648-784-02	2020-01-31	C162847	48780-1	9d75b9d0-2c26-f424-e053-dadaa90a57ce	Carbidopa, Levodopa and Entacapone Tablets
55648-784-03	2020-01-31	C162847	48780-1	9d75b9d0-2c26-f424-e053-dadaa90a57ce	Carbidopa, Levodopa and Entacapone Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55648-784-02	carbidopa, levodopa and entacapone	100 in 1 BOTTLE	TABLET, FILM COATED	100		3
55648-784-03	carbidopa, levodopa and entacapone	500 in 1 BOTTLE	TABLET, FILM COATED	500		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBIDOPA	ACTIVE INGREDIENT	MNX7R8C5VO	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
ENTACAPONE	ACTIVE INGREDIENT	4975G9NM6T	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
LEVODOPA	ACTIVE INGREDIENT	46627O600J	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
CARBIDOPA	ACTIVE MOIETY	MNX7R8C5VO	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
ENTACAPONE	ACTIVE MOIETY	4975G9NM6T	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
LEVODOPA	ACTIVE MOIETY	46627O600J	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55648-784	CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	3	Legacy NDC, 2 package rows	20120530_dabb7f5d-03b3-4d46-951a-e41a1f8d69cc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa, Levodopa, and Entacapone	CARBIDOPA, LEVODOPA, AND ENTACAPONE	Sandoz Inc	9c16c0e0-3b97-486b-b7d5-579f5853e2c5	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021485 application number: NDA021485

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MNX7R8C5VO	CARBIDOPA	38821-49-7	CARBIDOPA
4975G9NM6T	ENTACAPONE	130929-57-6	ENTACAPONE
46627O600J	LEVODOPA	59-92-7	LEVODOPA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403850	carbidopa 12.5 MG / levodopa 50 MG / entacapone 200 MG Oral Tablet	PSN	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
810090	carbidopa 18.75 MG / levodopa 75 MG / entacapone 200 MG Oral Tablet	PSN	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
403851	carbidopa 25 MG / levodopa 100 MG / entacapone 200 MG Oral Tablet	PSN	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
810083	carbidopa 31.25 MG / levodopa 125 MG / entacapone 200 MG Oral Tablet	PSN	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
403852	carbidopa 37.5 MG / levodopa 150 MG / entacapone 200 MG Oral Tablet	PSN	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
730988	carbidopa 50 MG / levodopa 200 MG / entacapone 200 MG Oral Tablet	PSN	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
403850	carbidopa 12.5 MG / entacapone 200 MG / levodopa 50 MG Oral Tablet	SCD	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
810090	carbidopa 18.75 MG / entacapone 200 MG / levodopa 75 MG Oral Tablet	SCD	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
403851	carbidopa 25 MG / entacapone 200 MG / levodopa 100 MG Oral Tablet	SCD	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
810083	carbidopa 31.25 MG / entacapone 200 MG / levodopa 125 MG Oral Tablet	SCD	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
403852	carbidopa 37.5 MG / entacapone 200 MG / levodopa 150 MG Oral Tablet	SCD	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
730988	carbidopa 50 MG / entacapone 200 MG / levodopa 200 MG Oral Tablet	SCD	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
403850	Carbidopa 12.5 MG / entacapone 200 MG / L-DOPA 50 MG Oral Tablet	SY	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
810090	Carbidopa 18.75 MG / entacapone 200 MG / L-DOPA 75 MG Oral Tablet	SY	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
403851	Carbidopa 25 MG / entacapone 200 MG / L-DOPA 100 MG Oral Tablet	SY	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
810083	Carbidopa 31.25 MG / entacapone 200 MG / L-DOPA 125 MG Oral Tablet	SY	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
403852	Carbidopa 37.5 MG / entacapone 200 MG / L-DOPA 150 MG Oral Tablet	SY	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3
730988	Carbidopa 50 MG / entacapone 200 MG / L-DOPA 200 MG Oral Tablet	SY	dabb7f5d-03b3-4d46-951a-e41a1f8d69cc	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55648-784-02	55648078402	100 in 1 BOTTLE	Historical
55648-784-03	55648078403	500 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbidopa, Levodopa and Entacapone Tablets	Wockhardt Limited \| Orion Corporation, Orion Pharma	2012-05-28	HUMAN PRESCRIPTION DRUG LABEL	3